Alfasigma has expanded its drug portfolio for treating rare and serious liver diseases after completing its acquisition of US-based Intercept Pharmaceuticals.

The completed acquisition comes just over a month after Intercept agreed to a $794m (€751.76m) buyout by Alfasigma. Any remaining common shares of Intercept were bought at $19.00 per share. 

Now being owned by the leading Italian pharmaceutical company, Intercept will no longer be traded on the Nasdaq exchange. In acquiring Intercept, Alfasigma has gained access to Ocaliva, the only US Food and Drug Administration (FDA)-approved second-line therapy for primary biliary cholangitis (PBC).

Ocaliva, in combination with bezafibrate, also has orphan drug designation for PBC that was granted by the FDA in May.

As per Alfasigma CEO Francesco Balestrieri, the company seeks to expand its gastroenterology and hepatology market presence and will benefit from Intercept’s innovation and R&D pipeline.

Though Intercept’s Ocaliva has had its victories, the drug has also faced a number of setbacks in the race to become the first approved treatment for nonalcoholic steatohepatitis (NASH)-associated liver fibrosis on the market.

In an overwhelmingly negative 12-2 vote by an FDA Advisory Committee (AdCom) in May, panelists spurned the drug as they were skeptical about efficacy claims based on the trial’s surrogate endpoint data. The Phase III REGENERATE (NCT02548351) study was eventually terminated in June after the FDA issued a negative complete response letter (CRL) to Intercept, which then decided to “wind down” its NASH-related plans entirely. The process of shutting down the trial is expected to be completed at the end of this year.

In the past year, Alfasigma has made a number of portfolio-strengthening moves both domestically and abroad.

In a bid to strengthen its European market, the company signed a letter of content to acquire rheumatoid arthritis and ulcerative colitis drug, Jyseleca (filgotinib), from Belgian biotechnology company Galapagos in October. As a result, Alfasigma will gain control over EU and UK marketing rights and developmental activities for the drug.

Jyseleca was also being studied as a potential therapy for Crohn’s disease (CD) but the Phase III DIVERSITY1 (NCT02914561) study for patients with moderate to severe CD failed to meet one of its co-primary endpoints.

Alfasigma also completed the acquisition of Italian pharmaceutical company SOFAR in October 2022.

By adding Ocaliva to the company’s basket, Alfasigma has taken an important step in establishing a strong presence in the US market, explained chairman Stefano Golinelli.